Doug Rafferty Senior Consultant Pacific Region Immuno Laboratories 800-231-9197 Ext: 6414

1. Doug Rafferty Senior Consultant Pacific Region Immuno Laboratories 800-231-9197 Ext: 6414 DougR@immunolabs.com

2. Who is Immuno Laboratories Founded by Jeffery Zavik in 1978 Immuno labs has been in business for over 30 years Help develop the Elisa method for IgG testing. We are considered by most to be the premier laboratory in the world for food allergy testing We maintain 95% reproducibility We are the only lab in the world with a Money Back Guarantee

3. Welcome! You have made a wise decision to be here if you love… • The independence of your own practice. • Using your own professional discretion to bring benefit to your patients. • To develop a reputation as the doctor who provides lasting relief, even when all previous attempts have failed.

4. What we believe… • Helping you fulfill the reason you became a Physician… To help people get relief and make a exceptional difference in the quality of people’s lives. • The right food is your first and best medicine. • The value of partnering and long-term relationships. • Donating a portion of our profits to the Make-A-Wish Foundation.

5. Our solutions… • Are easy to implement. • Do not require extraordinary attention. • Will not take you away from your practice of medicine. The Immuno Advantage: • Accurate, reliable testing with prompt turnaround • Patient support 24/7 online and DVDs • Marketing and practice growth consulting

6. Published studies Sub-fraction, Gluten, tTG and Candida testing Allergy and Health-Related Quality of Life (HRQL) Review Submit Q/A cards Personal story Core test: Immuno One Bloodprint™ Delayed vs. Immediate ELISA method The Immuno Method Independent proof of the superiority of Immuno Method Summary…

7. Symptoms: Wife MS Exacerbation lasting 9 months 24 pills a day Painful daily shot Self-discovery: On-line MS research showed elimination of IgG food allergies could help Symptoms: Children ADHD/ADD Controlled Summer Diet Significant Improvement Back to school: Symptoms returned. Committed to helping pt’s A personal story… Lifelong Lesson: “The right food is your first and best medicine”

8. Core Test: IgG Food Allergy Immuno 1 Bloodprint™ • Since 1978, >300,000 tests • 95% immune reactions to foods are IgG delayed symptom onset. • Type 2, IgG delayed reactions are common in children, adults… • Over 50 medical conditions • Over 100 symptoms have been reported to be provoked, worsened or caused by immune reactions to foods. “Virtually any tissue, organ or system can be affected by an IgG delayed allergy.”

9. Immediate (Type 1) Allergy • Examples: Reactions to penicillin, shrimp, peanuts • Affects 10% population • Grass and tree pollen, animal dander, some foods • New 3rd generation IgE presents breakthrough opportunities

10. Involves 3 to 20 foods Few reactions from one food challenge Delayed symptoms 2-72 hours Affects any tissue, organ Common in children and adults Delayed vs ImmediateIgG compared to IgE food testing • Involves 1 to 2 foods • Severe reactions from one food challenge • Immediate symptoms • Affects primarily skin, lungs, digestion • Estimates less than 10% of the population affected

11. IgG Delayed Food Allergy Facts • IgG antibodies specific to foods useful to diagnose and treat: - GI disturbances, asthma, migraine, fatigue, depression, chronic sinus and skin conditions, ADHD, and more. • IgG reactive foods rarely self-diagnosed (delayed symptom onset). • Single blood test can test many food specific IgG antibodies. • Immuno 1 Bloodprint: 154 food comprehensive Panel • Optional: 115 Std food, 88 food, Vegetarian, and Kosher panels • Additional Tests: Anti-Gliadin (Gluten), Tissue Transglutaminase (tTG for Celiac Disease), Candida Albicans, Milk Sub- Fraction, Egg Sub-Fraction • Symptoms often clear following 3-6 months of avoidance and nutritional therapy.

12. Easy Access to Published Studies… “9652 published articles on food hypersensitivity”

13. Immuno Laboratories’ ELISA Method ELISA… • Enzyme Linked Immuno Sorbent Assay • RAST often used generically for allergy blood tests (Radio Allergo Sorbent Test) • RAST completely different method (radioactive isotopes) • We produce our own test kits

14. The ELISA Method… • Food antigens are absorbed onto each well. • Patient’s serum is added. • If specific antibodies, they bind to the food antigen. • Anti-globulin is added which binds to the bound antibody. (binding is not visible). • Substrate is added to produce a visible color change measured by computer-interfaced spectrophotometer.

15. History Behind Our Quality Control • Q/C processes begin with how we interpret the raw testing data. • Began over 20 years ago with lab director, John Rebello, PhD. • Dr. Rebello’s biological manufacturing background involved the isolation of plasma proteins. (plus rubella, mumps, human plasma). • Dr. Rebello faced key IgG challenge: No standardization of food antigen potency (applied knowledge of biological manufacturing). • Challenge: Determining the optimal CLINICAL potency for food antigens (applied knowledge of manufacturing blood banking kits). • Solving the standardization and optimization of antigens = Clinically significant, reproducible results.

16. Over 37 Quality Control Steps • Dr. Rebello set the stage for an accurate, reproducible test when he established the standardization and optimization of the food antigens. • Next step required customized computer software to adjust absorbance readings for each sample well and convert the raw data to a scoring scale for IgG antibody levels: 0 Non-detectable +1 Low +2 Moderate +3 High +4 Very High • CLINICAL NOTE: • Lack of correlation of symptoms with degree of reactivity • Clinicians report patients with multiple IgG reactions associated with systemic challenges such as candida

17. Quality Control For Every PatientWeekly Reproducibility Tests • Positive and negative controls as well as internal standards are included on each micro titer plate. • Split sample Quality Control • Each week a serum sample is aliquot into two separate tubes and tested on the same day. • Results of the two tests are compared and satisfactory if the error rate is less than 10%. • Split sample testing files for over 15 years. • Follow split sample protocol to conduct your own split sample testing.

18. Quality Control: Test Materials • FDA approved antigens • Highest quality plates (individually wrapped)

19. Test results and program • Color-enhanced personalized test report lists foods tested and +1 to +4 reactivity. • Treatment: Elimination 3 to 4 months; reintroduce, rotate. • Various food plan report formats available. • 100’s of physician, patient letters and video taped interviews on file.

20. DOUBLE BLIND PLACEBO DIET CONTROLLED CROSSOVER STUDY OF IgG FOOD ELISA • Sidney Baker, MD (Yale University School of Medicine, New Haven, CT) • Presented at the American Academy of Environmental Medicine Conference, Virginia Beach, VA, October 1994 • Hypothesis: • Symptom improvement should occur to a greater degree in subjects who avoid foods identified as reactive by IgG ELISA as compared with subjects placed on a placebo diet containing foods patient is reactive to. • Method: • Potential subjects responded to newspaper ad for a food allergy study. • Participants tested by ELISA for IgG antibodies to foods. • Extensive questionnaire was used to record symptoms. • 3 male and 12 female subjects completed the study. • The subjects were randomly assigned to groups, A or B.

21. Double-Blind Placebo-Diet Controlled Crossover IgG ELISA

22. Double-blind outcome… “Significant p = 0.00024 favoring the avoidance of IgG reactive foods compared to placebo diet…” - Sidney Baker, M.D.

23. Bastyr University IgG findings • IgG Food Allergy Testing By ELISA: What do they really tell us? • Researcher: Sheryl B. Miller, MT (ASCP), PhD, Clinical Laboratory Director, Bastyr University Natural Health Clinic “Before the validity of a laboratory test can be assessed, however, the reproducibility or reliability of the test must be evaluated and confirmed. In the world of laboratory testing, if a test is not reproducible, it is considered worthless. The validity of a test or its correlation with disease states is irrelevant if a test is not reliable.”

24. More Bastyr Research outcomes… “Lab C (Immuno Laboratories) had more reasonable variances in its testing results. There was only an average 9% numerical variance between all the samples. This correlated to a 9% clinical variance because all positives by this lab were considered significant. Both of the variances from Lab C, numerical and clinical interpretation, were well within accepted laboratory standards.” “In conclusion, two of three labs tested had numerical variances outside acceptable laboratory standards and are not considered reliable.”

25. Comparing lab to lab results… • No industry IgG standards • Fact: Lab A: Lab B results vary • Choose your lab wisely

26. Foods Linked to Migraine Relief… “The study gave two lines of evidence which indicate that migraine has an etiology of food sensitivity” - Annals of Allergy, 1985

27. Foods Linked to IBS… “…excluding foods to which patients have IgG antibodies might be particularly beneficial in IBS” - Gut, 2004/2005

28. Foods Linked To ADHD… “Dietary factors may play a significant role in the etiology of the majority of children with ADHD. The most common food allergens were eliminated from diets as well as all artificial colors and preservatives. After elimination 19 of the 26 children (73%) improved significantly” - Annals of Allergy, 1994

29. Sub-fraction testing… • Sub-fraction tests pinpoint what is toxic within a common food. • Milk sub-fractions: Casein, whey, alpha lactalbumin, beta lactoglobulin, bovine serum albumin, lactoferrin • Egg sub-fractions: egg white, egg yolk

30. Anti-Gliadin Antibody Profile… • Over 100 chronic conditions, including celiac disease, associated with increased levels of anti-gliadin antibody. • Gliadin is the protein component of gluten. • Intolerance to the protein of wheat, rye, oats and barley causes gluten sensitive enteropathy (GSE).

31. Anti-Gliadin/ tTG Facts… • Anti-gliadin IgG and IgA linked to medical conditions. • Elevated gliadin antibodies: epilepsy, autism, anemia, arthritis, urticaria, headaches. • Detects IgG and IgA. • Tissue transglutaminase (tTG) when either anti-gliadin IgG, IgA or both are elevated. • Tissue transglutaminase is an intracellular enzyme released upon cell damage or wounding. • IgA antibodies to tTG: high correlation to celiac disease.

32. Antigliadin Antibodies: Absence of Celiac “The emergence of Antigliadin antibodies in immunomediated diseases may be attributed to the response to food protein in pathological conditions and is often unrelated closely with celiac disease.” - Klin Med, 1998

33. Celiac disease links “Non-invasive screening tests should be used systematically in groups considered to be at risk of celiac disease. These include insulin-dependent diabetes mellitus, iron-deficiency anemia, epilepsy with cerebral calcification…other conditions will probably be identified in the near future.” - Baillieres Clin Gastroenterol, 1995

34. Autism: Gluten/Gliadin Connection… • Physicians and families report that autistic individuals on diets free of gliadin show significant improvement. • Food Allergies Linked to Autism? by Sidney Baker, M.D. Source: http://www.betterhealthusa.com/public/158.cfm

35. The Food - Autism Link … “The pathology, reported to extend from the esophagus to the colon, is described here along with other studies pointing to a connection between diet and the severity of symptoms expressed in autism.” “The pathology, reported to extend from the esophagus to the colon, is described here along with other studies pointing to a connection between diet and the severity of symptoms expressed in autism” - Exp. Biol. Med (Maywood) 2003

36. The Leaky Gut - Autism Link “We speculate that an altered intestinal permeability could represent a possible mechanism for the increased passage through the gut mucosa of peptides derived from foods with subsequent behavioural abnormalities.” - Acta Paediatr. 1996

37. Candida Albicans Facts… • A form of Candidiasis (often systemic) causes symptoms. • Origination: Overgrowth of Candida fungal form in lower GI tract. • Causes: Steroids, antibiotics, oral contraceptives, diet high in yeast-containing foods, sugars and refined carbohydrates. • Candida overgrowth in GI tract may predispose patient to food allergies, resulting from leaky gut syndrome. • Combination of food allergy and candida testing supported with our nutritional food plan proven very effective in helping to heal and restore healthy intestinal lining.

38. Candida Albicans Immunodiffusion Assay… • Classic technique to detect antigen-antibody reactions. • Antigens and antibodies placed in separate wells in gel matrix diffuse towards each other. • Positive reactions: Precipitate forms as opaque line. • In 1986, physicians reported: Patients exhibited candidiasis symptoms yet test results were negative. • Need to research more sensitive test options.

39. Candida Albicans ELISA Assay • Uses cytoplasmic protein of Candida albicans as antigen to detect specific IgG. • Challenge: Cytoplasmic antigen. • Opportunity: Correlate positive test results with patient symptoms. (11 Doctors, 400 patients). • Reported as antibody titers. • ELISA: High sensitivity, specificity in detecting early stages of candidiasis. (allows early initiation of therapy).

40. Candida, Leaky Gut, Food Allergy “These results suggest that G.I. Candida colonisation promotes sensitisation against food antigens, at least partly due to mast cell mediated hyperpermeability in the GI mucosa of mice.” - Gut, 2006

41. Physician’s Test Indicator Guide… GLIADIN 17/22 Gliadin-related symptoms are found on Symptom Checklist. CANDIDA 32/47 Candida-related symptoms are found on Symptom Checklist.

42. NEW: 3gAllergy™ IgE testing • The first FDA-cleared 3rd generation allergy test. • Quantitative determination of allergen-specific IgE at very low levels. • Accurate, reproducible. • Automation delivers reliable results in about 1 hour.

43. New Opportunity: IgE Immunotherapy • Treatment sets compounded for each patient. • Usually 4 vials of increasing concentrations. • Subcutaneous injections over 25 week period. • Before shipping, vials subjected to FDA 14-day sterility test. • Substantial income potential.

44. Allergic Diseases and HRQL “Allergic diseases can deeply interfere with patient’s Health Related Quality of Life, with detrimental effects on the physical, psychological, and social dimensions of life.” - Ann. Allergy Asthma Immunol. 2006

45. Hypersensitive Children - HRQL “…food hypersensitivity must be considered to have a strong psychosocial impact.” - Health Qual. Life Outcomes 2006

46. The Immuno Advantage Accurate, reliable testing, prompt turnaround Patient support 24/7 online and DVDs Marketing and practice growth consulting 3 Reasons To Choose Immuno…

47. Patient Support

48. Customized Marketing

49. Customized Newsletters

50. Ongoing Support… • Phone or email with any questions or concerns • 954.691.2500 • cstwebmail@immunolabs.com • 24/7 on-line Fourm at www.betterhealthusa.com